Clincosm LogoSign in Get a demo

ESTROTIMP: Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer

Sponsor
Zionexa (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05486182
Collaborator
GE Healthcare (Industry), Simbec-Orion Group (Industry), Keosys (Other)
152
Enrollment
1
Location
1
Arm
39.7
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC).

Each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria.

After inclusion, a standardized pre ESTROTEP PET/CT questionnaire will be completed by the investigators to evaluate the initial management plan. Patient will perform the ESTROTEP PET/CT examination at visit 2. A standardized post ESTROTEP PET/CT questionnaire will then be completed by the investigators.

Patients will be followed for 12 months to evaluate their clinical status and standard of care investigations.

Condition or Disease Intervention/Treatment Phase
  • Drug: 18F Fluoroestradiol Radiopharmaceutical with PET/CT
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
152 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Impact of 18F-fluoroestradiol (FES) Positron Emission Tomography (PET) on the Therapeutic Treatment of Metastatic Breast Cancer Ipatients, Initially ER Positive and HER2 Negative, in Relapse After First-line Therapy Combining Hormone Therapy
Actual Study Start Date :
Feb 8, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prospective population

Drug: 18F Fluoroestradiol Radiopharmaceutical with PET/CT
Administration of one dose of 18F FES for PET/CT imaging
Other Names:
  • ESTROTEP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess the impact of ESTROTEP PET/CT on metastatic breast cancer patients management, initially ER+ and HER2-, in relapse after first-line treatment combining hormone therapy. [Change from baseline therapeutic measure at 15 days after ESTROTEP PET/CT]

      The percentage of patients for whom a substantial therapeutic measure was implemented following an analysis of the FES PET examination. This assessment will be performed prospectively by means of a standardised questionnaire completed by the prescribing clinician, when the request for an FES PET/CT is made. The therapeutic modality initially planned and the modality actually used may be determined by a multidisciplinary consultation meeting depending on the centre. This questionnaire will completed again within a maximum period of 15 days following the FES PET/CT in order to specify the final therapeutic measure. Substantial measures will be considered to be any major modifications made in terms of: therapeutic modalities, diagnostic modalities and follow-up modalities.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Woman aged at least 18 years old on inclusion

    2. Primary breast cancer expressing hormonal estrogen receptors in IHC (ER ≥ 10%)

    3. Primary breast tumor HER2 negative (0, 1+, 2+ FISH negative)

    4. Metastatic stage with at least one lesion identifiable on conventional work-up other than a hepatic lesion

    5. Patient in a situation of recurrence of the first line of treatment combining a CDK4 / 6 inhibitor and a hormone therapy

    6. Patient having performed a PET / CT with FDG during the follow-up of first metastatic line defining the relapse or performing a PET / CT with the baseline FDG defining the relapse during the extension assessment of 2nd line (according to the recommendations of the GBU of the examinations of 'medical imaging). A period of 2 to 28 days will be respected between the 2 PET / CT (FDG / FES).

    7. ECOG 0, 1 or 2

    8. Life expectancy of at least 12 months

    Exclusion Criteria:

    1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)

    2. Patients in the first metastatic line or beyond the second metastatic line

    3. Person with a known allergy to any of the components of EstroTep

    4. Patients who have been treated with a CDK4 / 6 inhibitor in combination with a first-line metastatic SERM or SERD

    5. Severe or known hepatic or renal failure

    6. Patient under a low salt diet or having an alcohol intake incompatible with EstroTep administration according to the investigator judgment

    7. Woman of childbearing potential without effective contraception according to the investigator judgement

    8. Serious intercurrent illness or co-morbidity assessed as risk

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CGFL Dijon France 21000

    Sponsors and Collaborators

    • Zionexa
    • GE Healthcare
    • Simbec-Orion Group
    • Keosys

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zionexa
    ClinicalTrials.gov Identifier:
    NCT05486182
    Other Study ID Numbers:
    • ZX-2021-FES-ESTROTIMP-4
    First Posted:
    Aug 3, 2022
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Radiopharmaceuticals

    Study Results

    No Results Posted as of Aug 3, 2022